Session 3: Regulation in the Regenerative Medicine Industry (Webinar)

The legal framework for market approval in Europe is provided by EU directives and regulations. There are two fundamental pieces of regulation for ATMPs: The European Tissue and Cells Directive (EUTCD) [Directive 2004/23/EC and implementing directives] and the Advance Therapy Medicinal Product (ATMP) Regulations (1394/2007 and 668/2009). European Medicines Agency and its Committee for Advanced Therapies (CAT) are the two most relevant regulatory bodies. A product may be an ATMP scientifically, but legally it may not be so. ATMP classification can be sought from CAT. Market authorisation can be sought nationally, through mutual recognition in a number of states, or centralised in the EU through the European Medicines Agency.